AB1400 ARE COMORBIDITIES IN PATIENTS WITH CHRONIC INFLAMMATORY RHEUMATIC DISEASES ASSOCIATED WITH TREATMENT NON-ADHERENCE TO BIOSIMILARS IN A NON-MEDICAL SWITCH SCENARIO?
Authors: I. Redeker, S. Moustakis, S. Tsiami, X. Baraliakos, I. Andreica, B. Buehring, J. Braun, U. Kiltz
Journal: Annals of the Rheumatic Diseases (2022)

Background The availability of biosimilars has created a financial incentive to encourage non-medical switching if cheaper products are on the market. In patients with chronic inflammatory rheumatic diseases (CIRD), we have previously reported a relatively high retention rate after switching from originator etanercept to its biosimilar. However, this has been different in other studies and the reasons for non-adherence are poorly understood. Comorbidity has recently gained much attention in patients with CIRD and might be a reason for non-adherence. Objectives The aim of this study was to analyse the effectiveness and safety of systematic non-medical switching from originator adalimumab (ADA) to ADA ABP501 biosimilar (ABP) over 6 months in patients with CIRD and to investigate the influence of comorbidities on retention rates. Methods Patients with CIRD on originator ADA who switched to ABP subsequently from October 2018 onwards were identified from a large routine database and then followed for 6 months. The presence of comorbidities and disease characteristics as well as measures of disease activity, physical function and changes in treatment were documented at baseline (the time of switching from originator ADA to ABP), and at months 3 and 6. Longitudinal data including information on the clinical efficacy and safety of ABP, and the reasons for discontinuation were documented. Results A total of 111 CIRD patients on treatment with originator ADA were switched to the biosimilar ABP (Table 1). More than half of the patients (62%) had a Charlson comorbidity score of 0, though there were differences between disease subtypes. RA patients were comparatively older (mean age 65 years) and had the highest mean Charlson score (1.8). Treatment retention varied only slightly between patients with a Charlson score of 0 and those with ≥0 (Figure 1). In both groups, the majority of patients (90% vs 95%) continued therapy with ABP, while only a small proportion either switched back to originator ADA (6% vs 5%), switched to a different biologic (3% vs 0%), or dropped out (1% vs 0%). The main reason for back switch was the occurrence of adverse events, mostly subjective complaints, most frequently pain. Patients with a Charlson comorbidity score &gt; 0 tended to have poorer scores in trajectories of scores for disease activity and physical function stratified by disease subtype. Figure 1. Treatment retention after 6 months stratified by the Charlson comorbidity score Table 1. Patients and disease characteristics RA axSpA PsA Other N=23 N=68 N=15 N=5 Age (years), mean (SD) 65.1 (12.0) 47.3 (13.1) 51.1 (11.2) 41.8 (14.2) Women 60.9% (14) 32.4% (22) 53.3% (8) 40.0% (2) Disease duration (years), median (IQR) 4.0 (3.0-8.0) 5.0 (2.0-8.0) 4.0 (2.0-13.0) 7.0 (4.0-7.0) Duration originator ADA therapy (month), mean (SD) 43.8 (28.6) 39.4 (26.9) 34.7 (29.0) 60.9 (27.7) Charlson score, mean (SD) 1.8 (2.1) 0.6 (1.1) 0.7 (1.2) 0.2 (0.4) Gastroenterological comorbidities 26.1% (6) 22.1% (15) 6.7% (1) 0 Hepatic comorbidities 17.4% (4) 2.9% (2) 13.3% (2) 0 Hematological conditions 8.7% (2) 2.9% (2) 13.3% (2) 0 Cardiovascular comorbidities 60.9% (14) 32.4% (22) 33.3% (5) 60.0% (3) Neurological and psychological comorbidities 8.7% (2) 17.6% (12) 33.3% (5) 0 Metabolic comorbidities 21.7% (5) 7.4% (5) 26.7% (4) 40.0% (2) Osteoporosis 43.5% (10) 11.9% (8) 6.7% (1) 20.0% (1) Lung diseases 21.7% (5) 8.8% (6) 0 40.0% (2) Skin diseases 26.1% (6) 26.5% (18) 80.0% (12) 20.0% (1) Eye diseases 8.7% (2) 23.5% (16) 6.7% (1) 60.0% (3) Kidney diseases 13.0% (3) 10.3% (7) 0 40.0% (2) Conclusion Comorbidity had no influence on the biosimilar retention rate after 6 months in this study but the majority of patients did not have Charlson scores &gt; 0. However, disease activity and physical function tended to be worse among CIRD patients with comorbidity. Cardiovascular disease and osteoporosis were more often present in RA patients than in axSpA or PsA patients, while neurological and psychological comorbidities were more often observed in the latter. Disclosure of Interests Imke Redeker: None declared, Stefan Moustakis: None declared, Styliani Tsiami: None declared, Xenofon Baraliakos Speakers bureau: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Paid instructor for: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Consultant of: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Grant/research support from: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Ioana Andreica Speakers bureau: UCB, MSD, Novartis, Abbvie, Lilly, Janssen, SOBI, Consultant of: Lilly, Novartis, Galapagos, Amgen, Takkeda, SOBI, Grant/research support from: Lilly, Bjoern Buehring Speakers bureau: UCB, Amgen, Gilad/Galapagos, Biogen, Sanofi/Genzyme, Consultant of: UCB, Theramex, Gilead/Galapagos, Amgen, Abbvie, Juergen Braun Speakers bureau: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Consultant of: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Grant/research support from: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Uta Kiltz Speakers bureau: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, Pfizer.